Last month, the U.S. Food and Drug Administration (FDA) released its framework for evaluating the potential use of real-world evidence (RWE) to help support the approval of a new indication for a pre-approved medicine and satisfy post-approval study requirements. Development of the framework was required under the 21st Century Cures Act and is a first step toward meeting those requirements. NPC has been playing a leading role in encouraging the use of high-quality methodology and standards to conduct real-world research and helping decision-makers understand how to evaluate and use RWE. But how is RWE really being used and how will the FDA framework affect decision-makers beyond the FDA?
Please join the National Pharmaceutical Council and key stakeholders on Jan. 30 from 1 p.m. to 2 p.m. ET for a webinar that will showcase the potential implications of the FDA framework for patients, payers, manufacturers and other health care stakeholders. ...
Register now to attend the webinar.